Juno Therapeutics Inc, a subsidiary of Bristol-Myers Squibb – FDA EIR, Mar 18, 2022

An FDA surveillance inspection of Juno Therapeutics Inc. in Seattle, WA, was conducted from March 14 to March 18, 2022. The inspection, assigned by the Center for Biologics Evaluation and Research, reviewed aspects of Protocol No. JCAR017-BCM-003A, a global Phase 3 trial for JCAR017 (Lisocabtagene Maraleucel), involving 184 participants across 11 countries and 53 sites. The review adhered to the Bioresearch Monitoring Compliance Program 7348.810 and the Food, Drug, and Cosmetic Act, including clinical trial registration requirements under FDAMA and FDAAA.

Significantly, no FDA Form 483, Inspectional Observations, was issued at the close of the inspection, indicating an absence of formal regulatory violations. However, one key item was discussed with management: the initial Data Safety Monitoring Board (DSMB) meeting was not conducted in accordance with its charter's specified frequency or timing, particularly regarding the number of randomized or infused subjects at the time of the meeting. The firm provided documentation to explain this delay. Additionally, two follow-up serious adverse event reports were submitted late, though these did not alter previous assessments. Since no 483 was issued, no specific required actions were formally mandated by this report.